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Pharmaceutical Group of the European Union

PGEU

PGEU represents community pharmacists across 33 European countries through national associations and professional bodies.

Lobbying Activity

Meeting with Carlo Fidanza (Member of the European Parliament)

25 Nov 2025 · legislative update

Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur)

25 Nov 2025 · Review of the EU General Pharmaceutical Legislation

Meeting with Nicolás González Casares (Member of the European Parliament, Shadow rapporteur)

25 Nov 2025 · Pharmaceutical Legislation

Meeting with Dolors Montserrat (Member of the European Parliament, Rapporteur)

6 Nov 2025 · Review of the EU General Pharmaceutical Legislation

Meeting with Aurelijus Veryga (Member of the European Parliament)

5 Nov 2025 · How pharmacy services improve patient care

Meeting with András Tivadar Kulja (Member of the European Parliament, Shadow rapporteur)

29 Oct 2025 · Healthcare workforce

PGEU urges embedding community pharmacies in EU crisis governance

28 Oct 2025
Topic — The consultation seeks to establish a coordinated EU framework for health crisis preparedness.
Message — PGEU calls for including community pharmacies in EU and national emergency structures. They request authority for pharmacists to administer vaccines and provide point-of-care testing. The group advocates for integrating pharmacy networks into health intelligence systems.123
Why — Pharmacists would gain broader clinical responsibilities and fair compensation for new services.45
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Meeting with Ingeborg Ter Laak (Member of the European Parliament) and European Federation of Pharmaceutical Industries and Associations

27 Oct 2025 · CMA & Biotech Act

Meeting with Pietro Fiocchi (Member of the European Parliament)

16 Oct 2025 · Critical medicine act

Pharmacists urge integration into EU cardiovascular health pathways

15 Sept 2025
Topic — The EU initiative aims to strengthen cardiovascular health through prevention and innovation.
Message — Formally integrate pharmacists into national cardiovascular disease pathways with structured referral systems. Promote pharmacist-led prevention, screening, and adherence services as part of standard primary care. Ensure that artificial intelligence supports rather than replaces the pharmacist’s clinical role.123
Why — This would solidify the pharmacists' clinical role as essential primary healthcare providers.45
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Meeting with Vytenis Povilas Andriukaitis (Member of the European Parliament)

2 Sept 2025 · EU Health Policy

Response to Critical Medicines Act

27 Jun 2025

Medicine shortages have become a persistent threat to public health across Europe. Despite community pharmacists continued efforts to find solutions, we continue to see a negative impact on patients health and a concerning erosion of patients trust in the medicines supply chain. In 2024, pharmacists across the European Union (EU) spent on average 11 hours per week managing medicine shortages, three times more than a decade ago, diverting valuable time from other pharmacy services. European community pharmacists welcome the European Commissions proposal for a Critical Medicines Act as an important step to strengthen the security of supply and availability of critical medicines recognizing this as a strategic priority for the European Union. We urge policymakers to shape the Critical Medicines Act into an effective instrument that delivers tangible improvements on shortages of critical medicines. To achieve this objective, PGEU calls for: Sustainable incentives for pharmaceutical production: PGEU welcomes the introduction of incentives to stimulate manufacturing of critical medicines in Europe. However, any public support must be accompanied by strong supply obligations and contractual performance clauses, to ensure the effectiveness of the resources invested in securing patients continued access to critical medicines. Ensuring coordination across various medicine supply security initiatives: The Act should avoid duplication of efforts between the already existing Medicines Shortages Steering Group and the proposed Critical Medicines Coordination Group. Additionally, the Act should clarify the interconnections between the different identified lists of medicines, ensuring coherence between European and national level lists and implement a common definition of medicine shortages. It is also important to better define the scope of the Act by developing a list of vulnerable medicines with real fragilities in their supply chain. Strengthening oversight of supply obligations: EU and national authorities need enhanced oversight and enforcement capacities to ensure compliance with existing obligations and the effectiveness of the public financial support granted. It is important to guarantee patients continued access to medicines no matter where they live in the EU. This includes all Member States, including small countries. Leveraging strategic spending packages for security: Reinforcing health security should be recognized as a strategic objective of the EU. PGEU supports using new funding sources, including the new EUs defense spending package and the Competitiveness Fund, to finance the Critical Medicines Act provisions on security of supply and preparedness. Optimizing contingency stocks: Member States should optimize national obligations on contingency stocks of medicines through a coordinated European approach. PGEU recommends the harmonization and implementation of rolling contingency stocks at manufacturers level to avoid unnecessary waste of finished medicinal products. Improving public procurement of medicines: Public procurement processes must shift away from a sole focus on lowest price. Incorporating non-price criteria, Most Economically Advantageous Tender (MEAT) criteria, and splitting awards among multiple suppliers will enhance supply security and contribute to ensure continuity of treatment for patients. Swift adoption and implementation: PGEU urges the European Parliament and Council of the European Union to treat the Critical Medicines Act as a top priority and move quickly towards its adoption. Given the ongoing shortages impacting patients daily, while waiting for new legislative measures to enter into force, we invite all the stakeholders to do everything they already can, within their remit, to mitigate shortages.
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Meeting with Mohammed Chahim (Member of the European Parliament, Shadow rapporteur for opinion) and European Federation of Pharmaceutical Industries and Associations and

25 Jun 2025 · Roundtable Critical Medicines Act

Meeting with Tilly Metz (Member of the European Parliament, Shadow rapporteur) and Bureau Européen des Unions de Consommateurs and

13 Jun 2025 · Critical Medicines Act

Meeting with Dirk Van Den Steen (Acting Head of Unit Health and Food Safety) and Standing Committee of European Doctors and European Federation of Nurses Associations

2 Jun 2025 · Health workforce actions at EU level

Meeting with Olivér Várhelyi (Commissioner) and

28 May 2025 · Role of pharmacists in safe supply of medicines

Response to EU Strategy on medical countermeasures

8 May 2025

The Pharmaceutical Group of the European Union (PGEU), representing over 400,000 community pharmacists across more than 160,000 pharmacies, welcomes the European Commissions Medical Countermeasures (MCM) Strategy. We strongly support the Strategys aim to improve resilience and ensure timely supply of MCMs to improve Europes health security. Community pharmacists, as highly accessible healthcare professionals, are essential partners in achieving these goals. Drawing on lessons from the COVID-19 pandemic, we detail below our recommendations, to ensure that the strategy delivers for patients and for Europe's preparedness. Pharmacies have proven to be indispensable in health crises, maintaining care continuity and acting as the first line of advice, treatment, and consultation for many citizens. To fully harness this capacity, pharmacists must be formally integrated into EU and national emergency governance structures. We call for including pharmacists in DG HERA crisis structures to ensure a structured coordination with healthcare professionals. By embedding pharmacists in governance and planning, the EU can benefit from our practical know-how in managing medicine supply and MCM. Europes community pharmacies are ubiquitous healthcare hubs that can guarantee equitable, swift distribution of medical countermeasures during a crisis. To maximize the positive impact on healthcare systems, legal frameworks should empower pharmacists to directly administer or dispense key countermeasures. In most EU countries, pharmacists already vaccinate and provide point-of-care testing. The strategy should recognize the importance of enabling pharmacists to administer vaccines and emergency therapeutics where needed. Community pharmacists are also able to collect valuable real-world data (RWD) on how medicines are used in real life, generating real-world evidence (RWE) for better decision-making. The MCM Strategy should create channels to fully harness this potential, together with supporting mechanisms for pharmacies to contribute by reporting data on MCM usage, outcomes, and patient-reported effectiveness. Persistent medicine shortages have become a major public health concern in Europe. Community pharmacies across Europe spend on average 11 hours per week managing shortages. Pharmacists are daily confronted with managing patient care when shortages strike. The strategy should call for allowing community pharmacists to make full use of their skills, knowledge, and experience to find alternative treatments for their patients, being it by dispensing the same medicine in a different formulation or pack size, performing generic/therapeutic substitution through an adequate shared decision-making process or compounding a medicine. For community pharmacies, to contribute effectively during health crises, there must be sustainable support for the extra responsibilities and challenges this entails, including an adequate support for pharmacy services. The MCM Strategy should outline how pharmacies will be enabled and incentivized to remain resilient pillars of the health system when emergencies occur. We encourage the Commission to coordinate Member States efforts in reinforcing the sustainability of pharmacy services including vaccination, which plays a crucial role during crises. During the response phase, increased transparency, and timely communication on shortages and other issues to affected stakeholders shall be ensured. In this regard, PGEU sees as crucial the European shortages monitoring platform (ESMP) and the Medicines Shortages Steering Group MSSG as per Regulation (EU) 2022/123 of the European Parliament and of the Council of 25 January 2022, reinforcing the role of the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices.
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Response to Critical Medicines Act

26 Feb 2025

The Pharmaceutical Group of the European Union (PGEU) welcomes the European Commissions initiative for a Critical Medicines Act as a necessary step to improve the availability of medicines for European patients. PGEU represents over 400,000 community pharmacists across Europe, who are on the frontline of patient care and experience daily the impact of medicines shortages. PGEUs 2024 Medicines Shortage Report, annexed to this submission, provides clear evidence on this ongoing crisis. Over the last year, pharmacies have consistently faced high levels of shortages, with 61% of countries reporting that the situation has not improved compared to the previous years survey, where shortages were already exceptionally high. Community pharmacists spend an average of 11 hours per week managing shortages, diverting time from essential patient care and placing significant strain on pharmacy practice. Pharmacists play a crucial role in mitigating shortages by advising patients on alternatives, ensuring treatment continuity, and applying professional flexibilities to find solutions in cases of unavailability. Despite these efforts, the scale and persistence of shortages require a systemic response at the European level. Supply chain vulnerabilities remain particularly pronounced for critical medicines, where reliance on a small number of manufacturers and a concentrated supplier base has led to repeated disruptions. Recent EU-level initiatives, including the European Commissions Communication addressing medicine shortages in the EU with the subsequent revision of the General Pharmaceutical Legislation, the Critical Medicines Alliance, the European Medicines Agency, have significantly advanced the understanding of structural weaknesses in the medicines supply chain and laid the foundation for meaningful reforms. Building on this progress, the Critical Medicines Act presents a key opportunity to implement concrete, long-term solutions that will strengthen Europes manufacturing resilience and patients access to medications. The Act should introduce clear and enforceable measures that enhance the availability of medicines. The effectiveness of this initiative will depend on ensuring that investment in European production is targeted and sustainable, that manufacturers benefiting from public support are bound by strong obligations, that procurement models prioritize security of supply, and that pharmacists are fully integrated into shortages management strategies at both national and EU levels. Transparency and oversight by the authorities over the upstream supply chain must also be strengthened. To ensure equitable access to critical medicines across the EU, it is crucial to foster solidarity and coordination among Member States. Optimizing European and national stockpile management by progressively building buffer stocks to mitigate the impact of shortages without generating unnecessary waste will be a key measure, as well as evaluating and addressing the impact of parallel trade and manufacturers' supply quotas and allocations. Procurement policies play a crucial role in determining the robustness of medicines supply chains. Public procurement in the EU has prioritized cost minimization at the expense of supply security. The Most Economically Advantageous Tender (MEAT) approach should be further implemented in medicines procurement, ensuring that criteria such as supply security, diversification, and environmental sustainability are systematically incorporated into award decisions. The Critical Medicines Act should build on this momentum by encouraging Member States and the EU to harmonize these approaches and recognize pharmacists and pharmacies as key actors in the response to shortages. PGEU stands ready to collaborate with the European Commission and all the other stakeholders to ensure that the Act delivers meaningful and lasting improvements to the availability of critical medicines for European patients.
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Meeting with Catarina Martins (Member of the European Parliament)

4 Feb 2025 · medicine shortages

Meeting with Ingeborg Ter Laak (Member of the European Parliament)

31 Jan 2025 · Medicine shortages, pharmacies

Meeting with Aurelijus Veryga (Member of the European Parliament)

29 Jan 2025 · Exploring Ways to Support the Workforce of the Future

Response to Professional qualifications recognition of nurses, pharmacists and dental practitioners - training requirements update

12 Feb 2024

PGEU Response Public Consultation on the Draft Delegated act of the Recognition of Professional Qualifications Directive 2005/36/EC The Pharmaceutical Group of the European Union (PGEU) represents around 500.000 community pharmacists in almost 200.000 community pharmacies in the European Region. PGEU members are the national associations and professional bodies of community pharmacists in 33 European countries including EU Member States, EU candidate countries and EEA/EFTA countries. PGEU has long been calling for an update on the training requirements of the Professional Qualifications Directive, that sets out at EU-level the minimum standard training requirements for the profession of pharmacists. The rapid developments in the field of health in general and medicines in particular, crucial for the education of pharmacists, are essential to assure qualified healthcare professionals that integrate into the primary care workforce. PGEU welcomes the revision of the minimum training requirements as considered in the Draft Delegated act, particularly the provisions detailed in amending Article 44, paragraph 3, and the Annex V, point 5.6.1. of the Directive 2005/36/EC of the European Parliament and of the Council as regards minimum training requirements for the professions of nurse responsible for general care, dental practitioner and pharmacist. European community pharmacists believe that the results of the Spark Legal Network have sufficiently informed the update of the minimum training requirements for the profession of pharmacists. The changes introduced in the course of training for pharmacists, and the list of knowledge and skills that have been proposed in the draft Delegated Act showcase the development of the profession of pharmacists, successfully representing generally acquired progress for pharmacists training. Together with partners and stakeholders involved in pharmacists education (EAFP, EPSA, EIPG, EAHP), PGEU has published a Joint Statement on future modifications on the Directive on the Recognition of Professional Qualifications (https://www.pgeu.eu/wp-content/uploads/2019/04/Joint-Statement-on-future-modifications-on-the-Directive-on-the-Recognition-of-Professional-Qualifications.pdf). These suggestions sought to showcase the current training of pharmacists, built upon the spirit of modernization that was the basis of the last revision of the Directive. In addition, they added consistency to the text following the last modification to the provision of pharmacists activities as well as reflecting the scientific progress and innovation in practice. PGEU is pleased to see that the suggestions put forward, encompassing the results of the study from Spark Legal Network to which community pharmacists contributed to through PGEU , have been taken into account generally, showcasing the advances in the education of pharmacists. This represents a much-needed evolution of the minimum standards for the course of training for pharmacists, that was last updated 10 years ago. Pharmacists consider that including the following topics, knowledge and skills in the revision is beneficial and reflects the scientific and technical advancements of pharmacists training: biopharmaceutical technology, genetics and pharmacogenomics, immunology, clinical pharmacy, pharmaceutical care, social pharmacy, public health, health promotion and disease management, epidemiology, pharmacy practice, inter- and multidisciplinary collaboration, pathology and pathophysiology, pharmacoeconomics, information technology and digital technology. Furthermore, PGEU stresses that a balance should be attained between the theoretical and the practical training of the pharmacy degree, in order to reflect that the future generation of pharmacists have a well-balanced and equilibrated education, thus contributing to a transformative healthcare workforce.
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Pharmacists back shortage tools but defend paper leaflets

7 Nov 2023
Topic — The EU is updating pharmaceutical rules to ensure medicine affordability and supply security.
Message — PGEU supports tools to address shortages but wants electronic information to complement rather than replace paper leaflets. They request that the Directive maintain its scope to avoid including medicines compounded by pharmacists. They also seek alternatives to proposed antimicrobial vouchers.12
Why — This would allow pharmacists to continue compounding medicines to bypass supply shortages.3
Impact — Patients without digital access lose vital safety instructions if paper leaflets are removed.4
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Meeting with Tilly Metz (Member of the European Parliament) and European Patients' Forum (EPF) and

10 Oct 2023 · Pharma Package

Meeting with Stella Kyriakides (Commissioner) and

15 Sept 2023 · Meeting to discuss the revision of the pharmaceutical legislation

Response to Vaccine-Preventable Cancers

2 Feb 2023

The Pharmaceutical Group of the European Union (PGEU, the European organisation representing community pharmacists in Europe) welcomes the European Commission (EC) plan to propose a Council Recommendation on vaccine-preventable cancers to help EU Member States address the cancer risks linked to HPV and HBV infections. In particular, PGEU recognizes as relevant the proposed actions concerning vaccination against HPV, including measures for Member States, stakeholders and the EC to increase the uptake of vaccination among (pre)adolescent girls and boys; together with better monitoring of vaccination uptake, in particular for boys of that age. Community pharmacists in Europe also acknowledge the proposed measures concerning vaccination against HBV, calling for measures by Member States, stakeholders and the Commission to increase access to vaccination for all affected population groups, with a view to increasing vaccination uptake; and also focusing on better monitoring of vaccination uptake, in particular where there are data gaps.By the cross-border nature of AMR, European community pharmacists believe the EU has a particular responsibility to lead an ambitious, multi-sectorial response and support the implementation of National Action Plans to fight this growing phenomenon. With regard to these measures, PGEU identifies that the actions to increase vaccination update listed (reducing physical obstacles to vaccination; targeted communication efforts; and fighting mis- and disinformation) are suitable and appropriate for the current status in Europe. PGEU also welcomes the efforts of the EC in early dialogue with Healthcare Professionals in the frontline of vaccination strategies, through the involvement of the Coalition for Vaccination in which PGEU is a co-chair. Community pharmacists are highly trained healthcare professionals with an expert knowledge of medicines and common ailments, including communicable diseases. Community pharmacists are excellently positioned within European communities in primary care to provide information, advice, referral, treatment and preventative actions to reduce the burden of communicable and vaccine-preventable diseases. In addition to their core range of services and activities, community pharmacists across Europe are increasingly providing new and innovative services to complement wider efforts within health services to reduce the transmission of communicable diseases, improve effectiveness of treatment and increase vaccination coverage of the population. PGEU published the PGEU Best Practice Paper: Communicable Diseases and Vaccination, and the PGEU Position Paper on Cancer showcasing PGEU members best practices with regard to prevention of communicable diseases with a focus on Vaccination, and the community pharmacy contribution to Europes Beating Cancer Plan. The structural involvement of primary healthcare is vital to reach the prevention objectives effectively and make sure that EU citizens can make use of these services in an accessible and affordable manner. Pharmacists across Europe are already providing a wide range of professional services related to the prevention of cancer (smoking cessation services, nutrition advice, health promotion, public health campaigns) and recommending and administering (in some European countries) HPV and Hepatitis B vaccines. Additionally, community pharmacists in Europe are ready to contribute even further to a full implementation of the Europe Beating Cancer Plan.
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Meeting with Stella Kyriakides (Commissioner) and Standing Committee of European Doctors and

6 Apr 2022 · Meeting with European health professionals’ and paediatric associations to discuss COVID-19 vaccination of adolescents and children

Response to Recommendation for strengthened actions against antimicrobial resistance

23 Mar 2022

European community pharmacists welcome the initiative for a new EU recommendation calling for greater action on Antimicrobial Resistance (AMR). By the cross-border nature of AMR, European community pharmacists believe the EU has a particular responsibility to lead an ambitious, multi-sectorial response and support the implementation of National Action Plans to fight this growing phenomenon. AMR is highly linked to the extent in which antibiotics are used. At the same time, it is known that the vast majority of antimicrobials for human use are prescribed, dispensed and used within primary care. Therefore, there is a strong need for a multi-disciplinary, One Health approach also within primary care which structurally involves all professionals that interact with people on antimicrobials and infection prevention, and makes optimal use of their competences. Community pharmacists play pivotal roles in infection prevention and promoting antimicrobial stewardship through a wide range of professional services. They provide preventative action, screening, referral, disposal, treatment in the pharmacy and play a crucial role in public health campaigns promoting the correct use and disposal of antibiotics. Despite the fact that pharmacies are the settings in which most consultations with patients on the prudent use of antibiotics take place, several European countries still lack structural involvement and support of community pharmacists in National Action Plans on AMR. Moreover, it is known that pharmaceutical pollution is a key driver for AMR. It is therefore imperative to encourage adequate disposal of expired or unused antimicrobials, including through pharmacy-led disposal and collection schemes where implemented, to prevent the inappropriate use or reuse of these medicines by persons who were not originally prescribed them. At the same time, efforts should focus on developing new antimicrobials whilst safeguarding the availability of existing therapies in order to provide healthcare professionals with sufficient therapy options to treat infections in a responsible manner. Finally, despite the existence of the EU common logo to help patients identify legally operating online pharmacies, it is known that illegal purchasing of antimicrobials without a prescription online is still a widespread issue which should be addressed. We therefore recommend the following measures: 1. Ensure adequate support for patients to help combatting AMR in primary care by expanding and rewarding community pharmacy services aiming at: - Integrated infection prevention and health promotion, including vaccination services; - Responsible common ailment management; - Timely point-of-care testing; - Referral and rational prescribing, use and disposal of antibiotics. 2. Support increased collaboration and communication between community pharmacists, other healthcare profes¬sionals, regulators, industry, patients and the public on combatting AMR, specifically to achieve the following: - Prescriptions for antimicrobial medicines always clearly specifying the indication; - Greater use of electronic health and/or shared medication records; - Prescribing and dispensing of antimicrobials in pack sizes according to the duration of the treatment; - Ensuring that pharmacy-led disposal and collection schemes, where implemented, are appropriately funded. 3. Developing innovative incentive/business models for new antimicrobials which could stimulate the development of new antibiotics whilst guaranteeing continued access to existing antimicrobial therapies. 4. Combat extra-EU online sales of antimicrobials by encouraging the use of “bricks and mortar” pharmacies and and legal online pharmacies by better promotion of the EU common logo for online pharmacies. For more specific proposals and evidence on related good practices across several European countries, we kindly refer you to the attached PGEU Best Practice Paper on AMR.
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Response to Requirements for Artificial Intelligence

20 Jul 2021

The Pharmaceutical Group of the European Union (PGEU), the organization representing community pharmacists in 32 European countries, welcomes the European Commission’s Proposal for an EU Regulation on Artificial Intelligence (AI) to establish a legal framework on AI Systems. Please find the full PGEU feedback to the European Commission's Proposal attached hereto.
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Meeting with Margaritis Schinas (Vice-President) and

16 Jun 2021 · Supply chains for medicines

Meeting with Stella Kyriakides (Commissioner) and European Federation of Pharmaceutical Industries and Associations and

7 Jun 2021 · VTC meeting - Access to Medicines

Response to Evaluation and revision of the general pharmaceutical legislation

27 Apr 2021

PGEU welcomes the opportunity to provide input in the context of the European Commission roadmap/inception impact assessment on the Evaluation and revision of the general pharmaceutical legislation. Our contribution addresses the issues that have a direct impact on community pharmacy, namely security of supply of medicines including shortages, medicines accessibility, and environmental sustainability. In particular, we believe the revision of the general EU pharmaceutical legislation should aim at: • Developing a fair framework for pharmaceuticals which puts guarantees for security and timeliness of medicines supply for patients at its core; • Expanding the role and resources of the European Medicines Agency (EMA) in the coordination of Member States activities on the prevention and management of shortages in close collaboration with the Heads of Medicines Agencies (HMA). At national level, national pharmacy organisations should be closely involved in strategies related to the monitoring, prevention and management of shortages; • Ensuring increased transparency and timely communication to affected stakeholders such as community pharmacists to prevent and minimize the impact of shortages; • Developing fair and effective redistribution mechanisms for medicines available on the European market, to those patients who need them the most, regardless the EU country where they live, especially in times of health crises and other additional extraordinary circumstances, such as Brexit, which can have a strong impact on medicine supply in some countries; • Establishing further EU guidance to Member States on the import and export of medicines across borders to ensure that as a response to occurring medicine shortages the flow of medicines and medical devices across borders within the EU is better planned and coordinated; • Assuring effective compliance with EU and national laws related to the public service obligations of supply chain actors through further clarification of these obligations; • Confirming the complementary nature of electronic product information to the paper package leaflet as outlined in the joint EMA-HMA-EC Key Principles on Electronic product information for human medicines in the EU; • Reducing pharmaceutical waste caused by leftover medicines by ensuring that systems are in place to encourage the dispensing of quantities of certain risk medicines matching the duration of treatment as much as possible - for example by optimising the package sizes – and to collect leftover or expired medicines; • Develop and ensure compliance with environmental quality standards for pharmaceuticals as a measure to promote greener manufacturing.
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Meeting with Stella Kyriakides (Commissioner) and

30 Sept 2020 · Call with pharmaceutical and medical device supply Chain on COVID-19

Response to Requirements for Artificial Intelligence

10 Sept 2020

The Pharmaceutical Group of the European Union (PGEU), the organization representing community pharmacists in 32 European countries, welcomes the European Commission’s Roadmap aimed at addressing a number of ethical and legal issues raised by Artificial Intelligence (AI). We support the Commission’s general objective to ensure the development and uptake of lawful and trustworthy AI across the Single Market through the creation of an ecosystem of trust. As AI applications develop fast, that AI will have a major impact on society and on a wide array of sectors of the economy is no longer a question. In the healthcare sector, PGEU acknowledges the value of innovative technologies such AI and Big Data analytics and considers these technologies to be a useful tool to support health professionals and EU health systems. In routine pharmacy practice at national level, we recommend that these tools shall always be accompanied by the supervision of pharmacists’ expert and professional advice, to use them to improve workflow efficiency, while promoting patient safety, therapy effectiveness and offering the highest standard of pharmacy services and pharmaceutical care to patients. While we see great value in using AI in healthcare for enabling meaningful innovation, supporting health professionals and enhancing patient care, we are aware that it may also entail significant risks, for example in relation to the use of health and patient data. In order to fully harness the benefits of AI in healthcare, a key requirement is to develop trust by all stakeholders involved through guaranteeing a high level of data protection. Patient data must be processed under a high level of data protection standards within trustworthy infrastructures that enable the access to secure data services. It also has to be ensured that data access and analysis are amenable to European rules for privacy and data protection. Therefore, we consider an EU legislative initiative on AI, as envisaged under most policy options proposed by the Commission in the Roadmap, to be an adequate way forward to address the risks linked to the development and use of certain AI applications. We welcome in particular an EU legislative initiative following a risk-based approach as already defined in the White Paper on AI published in February 2020. Taking this into account, we support Commission’s ‘’Option 3’’ proposal in the Roadmap, with a preference for the second sub-option, recommending a EU legislative instrument which could be limited to ‘’high-risk’’ AI applications , including those which are likely to be deployed in the healthcare sector. We would as well support the proposed ‘’Option 4’’, which envisages to implement the sub-option above while taking into account the different level of risks that could be generated by a particular AI application. In view of the next steps in addressing ethical and legal issues related to AI, we urge the European Commission to involve community pharmacists, as experienced users of digital health tools, in the formulation of such policies as well as in the development of guidelines and methods on the deployment of AI in healthcare. To provide a full overview of our position on AI, please find attached to this feedback the PGEU Position Paper on Big Data & AI in Healthcare.
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Response to Pharmaceutical Strategy - Timely patient access to affordable medicines

7 Jul 2020

PGEU, the European organisation representing community pharmacists, welcomes the Roadmap on a Pharmaceutical Strategy for Europe. Please find below a summary of PGEU views in relation to the specific objectives the European Commission intends to pursue and in annex PGEU positions on the issues that are most relevant for community pharmacists. 1. Ensure greater access and availability of pharmaceuticals to patients PGEU supports the European Commission’s efforts to address the critical issue of medicine shortages, which today has a tremendous negative impact on patients and pharmacy practice. When developing laws, policies and business strategies that can affect the timely and adequate supply of medicines, it must be ensured that patients’ needs are put first. Effective compliance with EU and national laws related to the public service obligations of supply chain actors needs to be assured. We would also welcome a closer cooperation between the Member States and the European Medicines Agency to improve reporting, monitoring and communication on medicine shortages at EU level. This should go hand in hand with increased transparency and effective communication to affected stakeholders. Timely and complete information on (anticipated) shortages will reduce the negative impact on patients and will allow community pharmacists to better manage patient care and ensure continuity of treatment. PGEU considers that the European Medicines Verification system is not an appropriate tool to monitor shortages because it is not a track and trace system and it is not an accurate indicator of national supply and demand. 2. Ensure affordability of medicines for patients and health systems financial and fiscal sustainability PGEU welcomes efforts to ensure the affordability of medicines for patients and health systems financial and fiscal sustainability. In addition to the areas mentioned, PGEU believes that expanding and rewarding the role of community pharmacy and strengthening primary care systems are key policy levers to lead the way towards a more sustainable, inclusive and healthier future in Europe. 3. Enable innovation including for unmet medical needs in a way that harnesses the benefits of digital PGEU acknowledges the value of innovative technologies such as Artificial Intelligence (AI) as well as the access and analysis of Big Data and consider these technologies to be a useful tool to support health professionals and EU health systems. In routine practice at national level, these tools shall always be accompanied by pharmacists’ expert and professional advice to improve workflow efficiency, while promoting patient safety, therapy effectiveness and offering the highest standard of pharmacy services to patients. In the era of digitalization and multiple information sources, community pharmacy remains a trusted source of reliable and independent health information for patients. The potential use of real-world evidence including evidence generation in community pharmacies to evaluate effectiveness and therapeutic added value of innovative medicines in practice should therefore also be rewarded. 4. Support EU influence and competitiveness on the global level, reduce direct dependence on manufacturing in non-EU countries, seek a level playing field for EU operators PGEU also welcomes references made to address the environmental implications of production, use and disposal of medicines as well as promoting the rational use of medicines. Community pharmacists across Europe are ideally placed to advise patients on the appropriate handling and disposal of pharmaceuticals, including on antimicrobials. It should at all-time be ensured that actions to address the risk of pharmaceuticals in the environment do not jeopardise sufficient room for independent clinical decision-making by healthcare professionals on public health grounds.
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Meeting with Stella Kyriakides (Commissioner)

2 Jul 2020 · VC meeting: Exchange of views on the forthcoming Pharmaceutical Strategy

Response to Europe’s Beating Cancer Plan

10 Mar 2020

The association representing European community pharmacists (PGEU) welcomes the main ambitions of Europe’s Beating Cancer Plan as outlined in the European Commission Roadmap. We believe that the 4 domains identified in the Roadmap are each of crucial importance and should be tackled at a European level to meaningfully complement existing national cancer plans of EU Member States. Please find below some additional considerations related to the commitment of, and possible contribution of, European community pharmacists to Europe’s Beating Cancer Plan. Prevention: We would like to emphasize the importance of the structural involvement of primary healthcare to reach the prevention objectives effectively and make sure that EU citizens can make use of these services in an accessible and affordable manner. Community pharmacies across Europe are already providing a wide range of professional services related to the prevention of cancer such smoking cessation services, nutrition advice, participating in health promotion campaigns and recommending and administering (in some European countries) HPV and Hepatitis B vaccines. As a complementary instrument for the prevention agenda, we therefore also see a valuable opportunity in establishing a best practice sharing platform for prevention services in primary care. Early detection and diagnosis: In addition to the screening for breast, cervical and colorectal cancer, we see scope to increase the coverage of the target population for the screening of skin cancer. By structurally involving primary care services in these screening programmes and making effective use of available digital tools, we can improve access and convenience for the public. Community pharmacies are highly accessible to the public and most are equipped to carry out health checks for several non-communicable diseases and referral to the most appropriate healthcare provider / service when needed. In the area of cancer, community pharmacists are already successfully supporting population screening programmes for colon cancer in several EU countries. Treatment and care: In order to improve access and affordability of cancer treatments which can be administered at home, such as oral chemotherapy and self-administrable biological medicines, it is important to make use of the highly accessible network of community pharmacies in Europe. Today, we see however that in some European countries these medicines are still not accessible for patients through their local community pharmacy, which puts an unnecessary burden on patients and is an inefficient utilization of healthcare resources. Community pharmacists can supply these treatments close to patients’ homes accompanied with expert guidance on their optimal use, safety and adherence. Across Europe, community pharmacists are increasingly developing a structured service approach towards the support for oral chemotherapy in primary care. New medicine services, medication use reviews and adherence support programmes are just some examples of such services that have been implemented in several European countries and which have demonstrated their cost-effectiveness. Quality of life for cancer patients, survivors and carers: Community pharmacists have an important role to play in the provision of pain treatment, special nutrition, and management of chemotherapy side-effects for palliative patients. Community pharmacists can provide a prompt and continuous service to patients by ensuring that a supply of specialist palliative care medicines, including unlicensed medicines, are in stock in the pharmacy in order that prescriptions can be dispensed in a timely manner. Effective communication between the specialist palliative care nurse, prescriber and the community pharmacist should try to anticipate a patient’s need for medication and plan accordingly.
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Meeting with Anne Bucher (Director-General Health and Food Safety)

10 Apr 2019 · Current and future EU health priorities as well as the role of community pharmacists in ensuring quality of care and patient safety, improving public health and guaranteeing access to medicines and healthcare services

Response to European Electronic Health Record (EHR) Exchange Format

14 Dec 2018

The Pharmaceutical Group of the European Union (PGEU) welcomes the European Commission initiative to establish a Recommendation on a Format for a European Electronic Health Record (EHR) Exchange, aiming to secure cross-border access to electronic health records. Access to health records across borders both for patients and treating healthcare professionals, whilst ensuring that patient confidentiality and data protection rules are followed, is a very important opportunity for safer and more effective cross-border healthcare provision in the EU. At national level, community pharmacists use shared electronic healthcare/medication records (where accessible) to screen for potential interactions and contraindications, whilst they can also be used to convey information to professionals and patients and facilitate safety-related actions (e.g. medication recalls or safety alerts). Also for cross-border prescriptions community pharmacists need to perform an assessment, authentication and validation of the prescription and prescribed medication. Allowing provision of access to key clinical information such as the patients’ list of current medications, allergies and adverse reactions is therefore highly recommended to reduce medication errors, interactions and treatment duplication across borders. The continued promotion of cooperation among Member States’ health authorities to allow electronic health records to be linked with ePrescribing systems could also be promoted in the Recommendation. This could be included as part of the proposal of a way of working between Member States, relevant stakeholders and the European Commission to continuously improve and develop specifications and standards, implement the exchange format for Electronic Health Record and monitor uptake across the EU. For example, pharmacists could include information related to non-prescribed medication the patient is taking, so that all health professionals treating the patient can be informed of the complete medication record. This will help removing the current technical barriers which are preventing patients to take full advantage of the Directive on cross border healthcare. In addition to the invitation to Member States to adapt their legislative framework to secure access to Electronic Health Records across borders, the Recommendation should also address the outstanding legal and practical issues that are currently hindering the mutual recognition of medical prescriptions across Member States. It is also important to increase transparency on the national rules applying to such recognition. In some Member States EU rules on recognition of prescriptions have not yet been duly implemented into national legislation. In others, regardless of the implementation thereof, in some occasions community pharmacists, are facing difficulties to verify the authenticity and validity of prescriptions issued by a prescriber established in a Member State different from the one where the medicine is being dispensed. These make the cross-border recognition of prescriptions within the EU very difficult and may prevent patients to take full advantage of the cross-border healthcare directive. The community pharmacy profession also recognises the complementary and supportive role digital healthcare services can provide to public health and pharmacy practice, both at national level and across borders. Therefore, we welcome the initiative to propose a set of common technical specifications that aims to improve the secure cross-border data exchange, required for an effective digital transformation of healthcare in the Digital Single Market. In the implementation process of any digital technology in healthcare, we would like to stress the need for early involvement of experienced end-users such as community pharmacists to ensure endorsement, support and commitment of all users involved. Attached: eHealth Solutions in European Community Pharmacies
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Meeting with Vytenis Andriukaitis (Commissioner) and

3 May 2018 · HTA

Meeting with Arunas Vinciunas (Cabinet of Commissioner Vytenis Andriukaitis)

12 Dec 2017 · Health priorities of 2018

Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

10 Oct 2017 · Discussion on eHealth and Vaccination

Response to Best practices on retail regulation

23 May 2017

PGEU’s feedback to the Roadmap on Best Practices on Retail regulation We welcome the opportunity to provide feedback to the Commission’s Roadmap on Best Practices on Retail regulation. PGEU would like to make clear that pharmacy services and distribution of medicines in pharmacies cannot be compared to any other retail activity in the Single Market. PGEU’s claim is based on the special nature of services provided by pharmacists and on the special nature of the medicinal products, whose therapeutic effects distinguish them substantially from other goods. In this respect, below we list arguments/points following the structure of the roadmap: 1. Legal basis of the initiative; 2. Context and main policy objectives; 3. Subsidiarity Check; 4. Option mapping; 5. Data gathering and consultation approach. Please find the arguments in the full PGEU feedback attached to this online form.
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Meeting with Xavier Prats Monné (Director-General Health and Food Safety)

14 Mar 2016 · DG SANTE priorities on AMR and medicines storages